This intervention aims to develop and test the feasibility, acceptability, and preliminary effects of a "Digital Strolling" intervention among people with SMI. The intervention group will receive a "Digital Strolling" intervention, which consists of 20 minutes "Digital strolling" for 10 days, with lessons occurring once a day. The control group will receive passive observation of virtual walking videos only.
This study is a two-arm, pilot randomized controlled trial, which will be used to evaluate and compare the effects of the "Digital strolling" intervention and the passive observing control group. Twenty-four participants will be recruited from the Hong Kong Polytechnic University. Participants will be assigned to the "Digital Strolling" or control group. Participants in the "Digital Strolling" group will receive an arm swing virtual walking intervention, which consists of 20 minutes of virtual walking for 10 days and is conducted at home. Qualitative interviews with the "Digital Strolling" group will be conducted to understand their acceptability, usability, perceived strengths, and limitations of the intervention. While the one in the control group will receive 10 passive observing walking videos for 10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Participants in the intervention group will wear a head-mounted display and hold a controller to swing their arm and control the virtual avatar walking in the virtual world. The intervention will include 10 scenarios of virtual walking intervention (1 scenario daily, each lasting for 15-20 minutes).
Participants in the control group will be given 10 different walking videos in total, one for each day, each approximately 15 minutes in length.
School of Nursing, The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Feasibility: Time taken to recruit the sample
The total time taken to recruit the target sample size.
Time frame: The outcome will be assessed through study completion, which is expected to be an average of 6 months.
Feasibility: Recruitment rate
The percentage of eligible participants who provide informed consent.
Time frame: The outcome will be assessed through study completion, which is expected to be an average of 6 months.
Feasibility: Drop-out rate
The percentage of randomised participants who withdrew post-randomization
Time frame: The outcome will be assessed through study completion, which is expected to be an average of 6 months.
Acceptability: Adherence rate
Number of participants who completed the intervention modules as defined by the protocol.
Time frame: This outcome will be measured at the end of the 10-day intervention period.
Intervention satisfaction
Participant satisfaction will be explored via semi-structured one-to-one interviews to identify barriers and facilitators.
Time frame: The outcome will be assessed 1 week post-intervention.
Adverse event
Number of participants experiencing at least one adverse event
Time frame: The outcome will be assessed through study completion, which is expected to be an average of 6 months.
Chronic pain
Chronic pain will be measured using the Numerical Pain Rating Scale (NPRS), with higher score indicate higher pain level, 0 is none pain, 1-3 means mild pain, 4-6 meanes moderate pain, 7-9 means severe pain, 10 is severe and worst pain.
Time frame: Chronic pain will be assessed at pre-intervention and 1 week post-intervention.
Chronic pain
The chronic pain will also be measured using Brief Pain Inventory (BPI). This scale has two domains: pain severity and pain interference. Mean scores of item 3-6 and 9A-9G reflecting pain severity and pain interference respectively, higher scores indicating higher pain severity or pain interference.
Time frame: Chronic pain will be measured at pre-intervention and 1 week post-intervention.
Depression
Depression will be measured by the 2-item Patient Health Questionnaire and the 9-item Patient Health Questionnaire. The PHQ-2 has two items (depressed mood and anhedonia), with range from 0-6. Highest score represents higher level of depression symptom severity. The PHQ-9 has 9 items (range, 0-27), higher score also means higher level of depression, the severity score ranges are as follows: 0-4 no depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
Time frame: Depression will be measured at pre-intervention and 1 week post-intervention.
Sleep quality
Sleep quality will be measured using the Pittsburgh Sleep Quality Index. The total score of the scale ranges from 0 to 21; a higher score indicates lower sleep quality.
Time frame: Sleep quality will be assessed at pre-intervention and 1 week post-intervention.
Virtual presence
Classifying virtual presence will be assessed using the Igroup presence questionnaire. The questionnaire has three subscales (Spatial presence, involvement, and experienced realism). The questionnaire needs to calculate the average scores across the subscales, then compute an overall sense of presence by averaging these subscale means. Higher subscale means higher spatial presence, involvement, and experienced realism. The higher total scores mean a higher overall sense of presence.
Time frame: Igroup presence questionnaire will be assessed pre-test and 1 week post intervention
Self-efficacy for exercise
Self-efficacy for exercise scale will be measured using the Chinese self-efficacy for exercise scale. The total score of this scale ranges from 0 to 90; a higher score represents strong exercise self-efficacy.
Time frame: Self-efficacy for exercise scale will be assessed pre-test and 1 week post-intervention
Quality of life (The 5-level EuroQol of Life -5 dimensions)
Quality of life will be measured using the 5-level EuroQol of Life -5 dimensions. This scale scores ranged from -0.59 to 1, where 1 is the best possible health state.
Time frame: Quality of life will be assessed at pre-intervention and 1 week post-intervention.
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